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. 2007 Sep-Oct;1(5):197–203.

Table 1.

Phase III studies in advanced gastric cancer.

Regimen No. pts. Antitumor activity
Survival
Author (year)
Response rate P value Median P value
FAMTX 105 41% < .001 10.5 mo .004 Wils4 (1991)
FAM 103 9% 7.3 mo

FAMTX 30 33% NS 7.3 mo NS Kelsen5 (1992)
EAP 30 20% 6.1 mo

FP 103 51% < .01 9.2 mo NS Kim7 (1993)
FAM 98 25% 7.3 mo
5F - U 94 26% 7.7 mo

ECF 126 45% (n=111) < .001 8.9 mo < .001 Webb8 (1997)
FAMTX 130 21% (n=108) 5.7 mo

FAMTX 133 12% NS 6.7 mo NS Vanhoefer9 (2000)
FP 134 20% 7.2 mo
ELF 132 9% 7.2 mo

DCF 221 37% .0106 9.2 mo .0201 Moiseyenko10 (2005)
FP 224 25% 8.6 mo

IF 170 32% NS 9.0 mo NSa Dank11 (2005)
FP 163 26% 8.7 mo

FLO 112 34% NS Not maturedb Al-Batran12 (2006)
FLP 106 25%

ECF 263 38% NS v ( s. ECF) 9.9 mo Noninferiority of X over Fand O over C was demonstrated Cunningham13 (2006)
EOF 245 40% 9.3 mo
ECX 250 41% 9.9 mo
EOX 144 47% 11.2 mo

XP 139 41% (n=160) .03 10.5 mo NSc Kang14 (2006)
FP 137 29% (n=156) 9.3 mo

Abbreviations: FAMTX = 5-FU (5-fluorouracil)/doxorubicin/methotrexate; FAM = 5-FU/doxorubicin/mitomycin C; EAP = etoposide/doxorubicin/cisplatin; FP = 5-FU/cisplatin; ECF = epirubicin/cisplatin/5-FU; ELF = etoposide/leucovorin/5-FU; DCF = docetaxel/cisplatin/5-FU; IF = irinotecan/leucovorin/5-FU; FLO = 5-FU/leucovorin/oxaliplatin; FLP = 5-FU/leucovorin/cisplatin; EOF = epirubicin/oxaliplatin/5-FU; ECX = epirubicin/cisplatin/capecitabine; EOX = epirubicin/oxaliplatin/capecitabine; XP = capecitabine/cisplatin; NS = not significant.

a Primary end point was superiority in time to progression: 5.0 months for IF, 4.2 months for FP; NS.

b Primary end point was superiority in time to progression: 5.7 months for FLO, 3.8 months for FLP; NS.

c Primary end point was noninferiority in progression-free survival: 5.6 months for XP, 5.0 months for FP; noninferiority was demonstrated.